The following data is part of a premarket notification filed by Phamatech Inc. with the FDA for At Home Drug Test Models, 9308t And 9308x.
| Device ID | K070009 |
| 510k Number | K070009 |
| Device Name: | AT HOME DRUG TEST MODELS, 9308T AND 9308X |
| Classification | Enzyme Immunoassay, Barbiturate |
| Applicant | PHAMATECH INC. 10151 BARNES CANYON RD San Diego, CA 92121 |
| Contact | Carl Mongiovi |
| Correspondent | Carl Mongiovi PHAMATECH INC. 10151 BARNES CANYON RD San Diego, CA 92121 |
| Product Code | DIS |
| Subsequent Product Code | DJG |
| Subsequent Product Code | DJR |
| Subsequent Product Code | JXM |
| CFR Regulation Number | 862.3150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-03 |
| Decision Date | 2007-12-07 |